Effectiveness of the Internet Attachment-Based Compassion Therapy (iABCT) to improve the quality of life and well-being in a population with chronic medical illness: A study protocol of a randomized controlled trial (SPIRIT compliant)

Abstract

Background Chronic medical illnesses significantly and negatively affect the quality of life of individuals who suffer them and represent one of the most important challenges faced by healthcare providers and policy-makers due to its rising prevalence and high rates of comorbidity. Compassion-based interventions delivered over the Internet may be a useful approach to facilitate illness management and improve the quality of life of individuals with chronic medical conditions. Objectives The purpose of this study is to describe a protocol for a randomized controlled trial to test the efficacy of the Internet Attachment-Based Compassion Therapy (iABCT) to improve the quality of life and well-being of patients with chronic medical illnesses. Method A two-arm, parallel-group, randomized controlled trial (RCT) will be carried out, with three assessment points (baseline, 3-month, and 6-month) under two conditions: intervention group and control group (waiting list). The primary outcomes include the quality of life on the EuroQol 5-Dimensions Questionnaire (EQ-5D) and the Pemberton Happiness Index (PHI). Secondary outcomes, such as compassion, self-care behaviors, illness interference, self-criticism, symptomatology, attachment styles, social support, and illness perception, will be considered. Moreover, an assessment on satisfaction and usability will be carried out. A total of 68 participants as minimum will be recruited (34 per arm). Intent-to-treat mixed-model analyses without any ad hoc imputations will be conducted. Conclusions Findings of this study will provide new insights into the potential of self-applied compassion-based interventions (CBI) delivered online in the context of chronic medical illnesses, considering aspects of their implementation (e.g., facilitators, barriers) and mechanisms of change. Trial registration The study is registered under Clinicaltrials.gov (NCT04809610) and it is currently in the participant recruitment phase.